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Zabilugene almadenorepvec - Theriva Biologics

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Drug Profile

Zabilugene almadenorepvec - Theriva Biologics

Alternative Names: VCN-01

Latest Information Update: 27 Nov 2025

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At a glance

  • Originator VCN Biosciences
  • Developer AstraZeneca; Theriva Biologics; VCN Biosciences
  • Class Antineoplastics; Eye disorder therapies; Gene therapies; Immunotherapies; Oncolytic viruses
  • Mechanism of Action Cell death stimulants; Hyaluronidase stimulants; Immunologic cytotoxicity
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Adenocarcinoma; Retinoblastoma
  • New Molecular Entity No

Highest Development Phases

  • Phase II Adenocarcinoma
  • Phase I/II Pancreatic cancer; Retinoblastoma; Squamous cell cancer
  • No development reported Brain cancer; Ovarian cancer; Solid tumours

Most Recent Events

  • 13 Nov 2025 Theriva Biologics plans an End-of-phase II meeting with the US FDA and EMA for the phase III trial for Adenocarcinoma (First-line therapy, Metastatic disease) before the end of 2025
  • 13 Nov 2025 Theriva Biologics plans to discuss with regulatory body for a phase II/III trial in Retinoblastoma (In children) in the first half of 2026
  • 12 Nov 2025 Adverse event, efficacy and pharmacokinetics data from the phase IIb VIRAGE trial for Adenocarcinoma released by Theriva Biologics

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